Exertion; ExcessPhase 2/3GMR-RCT-EOSNCT03899454
Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress
A Phase 2/3 study testing Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract in people with Exertion; Excess and Oxidative Stress, run by Universitas Negeri Semarang at 1 site in Indonesia.
Trial summary
Treatments are an administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exertion; Excess, Oxidative Stress
- What is being tested?
- Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jul 2020to 15 Sep 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sedentary lifestyle
- apparently healthy person
- willing to use the smart-phone application for diet and physical activity monitoring
Who cannot join
- pathological appearance in ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of the Effect of G. Mangostana L Rind and Solanum Lycopersicum Fructus Extract to Prevent Exercise-induced Oxidative Stress
Treatments are an administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.
Read the detailed description
Double-blinded Randomized Clinical Trial
The population of study will involve sedentary men, the student in Universitas Negeri Semarang aged 18-25 years old, targetted populations are 30 subjects consist of 15 treatment group and the rest 15 placebo-control group. Voluntary sampling will be conducted. Information to the candidates delivered directly, leaflets, and social media broadcasting.
Two arm treatment to be given is an administration of a mixture extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.
The administration of extract treatment and placebo will be given for four weeks.
The primary effect that will be observed is the changes in malondialdehyde (MDA) and high-sensitivity Cardiac-Troponin I (hs-cTnI) level after an ergo-cycle exercise test.
The secondary effect of the treatment that will be observed is the baseline and post-treatment parameters of MDA levels.
- Conditions
- Exertion; Excess, Oxidative Stress
- Being tested
- Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract, Placebo Control
- Keywords
- exercise-induced oxidative-stress, Garcinia mangostana L rind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extractDrug
Also called Brand name: OKSI (Indonesian Food and Drug Administration POM registered number :TR 193324351)
Administration of mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)
Placebo ControlDrug
Also called placebo
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Extract administration | Experimental | administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) Receives: Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract |
| Control | Placebo comparator | Placebo Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change ergo-cycle exercise test response to MDA level after 4 weeks treatment
measuring exercise-induced oxidative stress, based on pre-and post-exercise MDA levels
Measured: 4 weeks
Change ergo-cycle exercise test response to hs-cTnI level after 4 weeks treatment
measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels
Measured: 4 weeks
Secondary outcomes (1)
Change from baseline MDA levels after 4 weeks treatment
measuring MDA levels baseline and post-treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start15 Jul 2020 (estimated)
- Primary completion15 Sep 2020 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Exertion; ExcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arm treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Negeri Semarang
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Research, Technology and Higher Education, Republic of Indonesia
- Responsible party
- Principal investigator, Mahalul Azam, Universitas Negeri Semarang
- Investigators
- Mahalul Azam, Principal investigator, Universitas Negeri Semarang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899454
- Sponsor's protocol ID
- RCT 201901
- Acronym
- GMR-RCT-EOS
- Status last verified
- Jul 2019
- First submitted
- 28 Mar 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Knez WL, Jenkins DG, Coombes JS. Oxidative stress in half and full Ironman triathletes. Med Sci Sports Exerc. 2007 Feb;39(2):283-8. doi: 10.1249/01.mss.0000246999.09718.0c.
PubMed 17277592Thompson PD, Stern MP, Williams P, Duncan K, Haskell WL, Wood PD. Death during jogging or running. A study of 18 cases. JAMA. 1979 Sep 21;242(12):1265-7.
PubMed 480538Eijsvogels T, George K, Shave R, Gaze D, Levine BD, Hopman MT, Thijssen DH. Effect of prolonged walking on cardiac troponin levels. Am J Cardiol. 2010 Jan 15;105(2):267-72. doi: 10.1016/j.amjcard.2009.08.679.
PubMed 20102930Tong TK, Kong Z, Lin H, He Y, Lippi G, Shi Q, Zhang H, Nie J. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial. Oxid Med Cell Longev. 2016;2016:4848015. doi: 10.1155/2016/4848015. Epub 2015 Dec 10.
PubMed 26783415Tjahjani S, Widowati W, Khiong K, Suhendra A, Tjokropranoto R. Antioxidant Properties of Garcinia Mangostana L (Mangosteen) Rind. Procedia Chem. 2014
Sutono, T. Efficacy of Garcinia mangostana L. (mangosteen rind extract) to reduce acne severity. Med J Indones. Vol. 22, No. 3, August 2013
Meechai I, Phupong W, Chunglok W, Meepowpan P. Dihydroosajaxanthone: A New Natural Xanthone from the Branches of Garcinia Schomburgkiana Pierre. Iran J Pharm Res. 2018 Fall;17(4):1347-1352.
PubMed 30568693Ali Hassan SH, Fry JR, Abu Bakar MF. Phytochemicals content, antioxidant activity and acetylcholinesterase inhibition properties of indigenous Garcinia parvifolia fruit. Biomed Res Int. 2013;2013:138950. doi: 10.1155/2013/138950. Epub 2013 Oct 31.
PubMed 24288662
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Effect of G. Mangostana L Rind and Solanum Lycopersicum Fructus Extract to Prevent Exercise-induced Oxidative Stress
- ClinicalTrials.gov ID
- NCT03899454
- Acronym / sponsor ID
- GMR-RCT-EOS / RCT 201901
- Conditions
- Exertion; Excess, Oxidative Stress
- Keywords
- exercise-induced oxidative-stress, Garcinia mangostana L rind
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas Negeri SemarangUniversity, hospital or other
- Collaborators
- Ministry of Research, Technology and Higher Education, Republic of Indonesia
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 15 Sep 2020 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatments are an administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.
Detailed description
Double-blinded Randomized Clinical Trial
The population of study will involve sedentary men, the student in Universitas Negeri Semarang aged 18-25 years old, targetted populations are 30 subjects consist of 15 treatment group and the rest 15 placebo-control group. Voluntary sampling will be conducted. Information to the candidates delivered directly, leaflets, and social media broadcasting.
Two arm treatment to be given is an administration of a mixture extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.
The administration of extract treatment and placebo will be given for four weeks.
The primary effect that will be observed is the changes in malondialdehyde (MDA) and high-sensitivity Cardiac-Troponin I (hs-cTnI) level after an ergo-cycle exercise test.
The secondary effect of the treatment that will be observed is the baseline and post-treatment parameters of MDA levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- two arm treatment
| Arm | Type | Receives |
|---|---|---|
| Extract administration | Experimental | Drug: Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extractadministration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) |
| Control | Placebo comparator | Drug: Placebo ControlPlacebo |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- sedentary lifestyle
- apparently healthy person
- willing to use the smart-phone application for diet and physical activity monitoring
Key exclusion criteria (1 listed)
- pathological appearance in ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extractAlso: Brand name: OKSI (Indonesian Food and Drug Administration POM registered number :TR 193324351)Administration of mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) | Drug | Extract administration |
| Placebo ControlAlso: placeboPlacebo Control | Drug | Control |
Primary outcome
Change ergo-cycle exercise test response to MDA level after 4 weeks treatment
Time frame: 4 weeks
measuring exercise-induced oxidative stress, based on pre-and post-exercise MDA levels
Change ergo-cycle exercise test response to hs-cTnI level after 4 weeks treatment
Time frame: 4 weeks
measuring exercise-induced oxidative stress, based on pre-and post-exercise hs-cTnI levels
1 secondary outcome
Change from baseline MDA levels after 4 weeks treatment
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 17277592Knez WL, Jenkins DG, Coombes JS. Oxidative stress in half and full Ironman triathletes. Med Sci Sports Exerc. 2007 Feb;39(2):283-8. doi: 10.1249/01.mss.0000246999.09718.0c.
- Background: PubMed 480538Thompson PD, Stern MP, Williams P, Duncan K, Haskell WL, Wood PD. Death during jogging or running. A study of 18 cases. JAMA. 1979 Sep 21;242(12):1265-7.
- Background: PubMed 20102930Eijsvogels T, George K, Shave R, Gaze D, Levine BD, Hopman MT, Thijssen DH. Effect of prolonged walking on cardiac troponin levels. Am J Cardiol. 2010 Jan 15;105(2):267-72. doi: 10.1016/j.amjcard.2009.08.679.
- Background: PubMed 26783415Tong TK, Kong Z, Lin H, He Y, Lippi G, Shi Q, Zhang H, Nie J. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial. Oxid Med Cell Longev. 2016;2016:4848015. doi: 10.1155/2016/4848015. Epub 2015 Dec 10.
- BackgroundTjahjani S, Widowati W, Khiong K, Suhendra A, Tjokropranoto R. Antioxidant Properties of Garcinia Mangostana L (Mangosteen) Rind. Procedia Chem. 2014
- BackgroundSutono, T. Efficacy of Garcinia mangostana L. (mangosteen rind extract) to reduce acne severity. Med J Indones. Vol. 22, No. 3, August 2013
- Background: PubMed 30568693Meechai I, Phupong W, Chunglok W, Meepowpan P. Dihydroosajaxanthone: A New Natural Xanthone from the Branches of Garcinia Schomburgkiana Pierre. Iran J Pharm Res. 2018 Fall;17(4):1347-1352.
- Background: PubMed 24288662Ali Hassan SH, Fry JR, Abu Bakar MF. Phytochemicals content, antioxidant activity and acetylcholinesterase inhibition properties of indigenous Garcinia parvifolia fruit. Biomed Res Int. 2013;2013:138950. doi: 10.1155/2013/138950. Epub 2013 Oct 31.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahalul Azam principal investigator
Universitas Negeri Semarang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract in people with Exertion; Excess and Oxidative Stress, run by Universitas Negeri Semarang at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahalul Azam, MD, PhD (+628122853982, mahalul.azam@mail.unnes.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change ergo-cycle exercise test response to MDA level after 4 weeks treatment (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899454, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.